Cleared Traditional

KROM-X LENS SYSTEM (K865103) - FDA 510(k) Clearance

Class I Ophthalmic device.

K865103 · Neo Optics, Inc. · Ophthalmic device
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Jan 1987
Decision
21d
Days
Class 1
Risk

K865103 is an FDA 510(k) clearance for the KROM-X LENS SYSTEM. Classified as Lens, Spectacle, Non-custom (prescription) (product code HQG), Class I - General Controls.

Submitted by Neo Optics, Inc. (Glendale, US). The FDA issued a Cleared decision on January 20, 1987 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5844 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Neo Optics, Inc. devices

Submission Details

510(k) Number K865103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1986
Decision Date January 20, 1987
Days to Decision 21 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 110d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HQG Lens, Spectacle, Non-custom (prescription)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5844
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.